How the African NMRAs are benefiting from the WHO medicines prequalification programme (PQP)

1. How the African NMRAs are benefiting from the WHO medicines prequalification programme (PQP) Mr. Apollo MuhairweExecutive Secretary/ Registrar, NDA Geneva, SWITZERLAND 11tH February 2010

2. Scope of Presentation • Introducing NDA Uganda • Why African NMRAs need the PQP • Benefits from PQP • PQP capacity building activities for NMRAs • Outcomes from PQP collaboration • Future plans • Conclusion

3. Introduction of NDA - Uganda National Drug Authority (NDA) is an autonomous Medicines Regulatory Authority for Uganda, established by in 1993 by an Act of parliament. It is governed by a board, called the Authority, which operates through several Expert Committees and the Secretariat. The Secretariat is headed by the Executive Secretary who is the Registrar and secretary to the Authority and all Authority committees. The Secretariat is composed of: 6 Departments : Drug Assessment and Registration (DAR) Drugs Inspectorate (INSP) National Drug Quality Control Laboratory (NDQCL) Drug Information Department (DID) - National Pharmacovigilance centre Finance Department Food Safety Desk (New) 4 Units: Legal, Human Resource, Audit, Procurement and Quality Management NDA has cooperated with the WHO Prequalification of medicines Programme (PQP) since 2004. We therefore have enough experience to share with you the benefits of the programme.

4. Why African NMRAs need the PQP • There is still limited access to treatment by millions of people living with HIV/AIDS, tuberculosis and malaria • Most countries still experience appearance of substandard and counterfeit products on their markets • A number of countries have weak or no Quality Assurance systems for medicines due to limited resources and qualified personnel/ Experts • A lot of money has been invested in procurement but there are no harmonized quality assurance systems for procurement organizations involved.

5. Benefits from PQP (1) • PQP provides expertise: • Detailed and user friendly easy to use Guidelines • In depth review of APIs • Inspection of API manufacturers, not done by some strong NMRAs • In-depth review of clinical/BE data including Inspection of CROs • Capacity building: • On the job training: • NMRA staff participate in assessments together with experts from PICS/ICH Regions • 3-months placements in Geneva for hands-on experience in everyday work of the PQ Programme and WHO. • Participation as observers in PQ inspections of CROs, API and FPP sites • Training of NMRA staff through workshops and seminars • Pre-visit to QC labs to advise on improvements necessary for prequalification.

6. Benefits from PQP (2) • Stimulates harmonization among • NMRAs: group assessments have passed on skills and built trust among regulatory staff from same region. This is the experience in the East African Community (EAC). • Manufacturers: Experience in submitting PQ dossiers improves appreciation of regulatory requirements, the quality of dossiers received by NMRAs has improved – same dossiers as submitted to PQP. • Platform for mutual recognition and networking • Has provided hands-on experience on how to collaborated between regulators in Africa and from ICH or PIC/S countries. • NMRAs using guidelines adopted from WHO-PQ and who have undergone similar training are finding it easy to share regulatory information. • Enhance reputation and public image of NMRAs • Participation of NMRAs staff in PQ has enhanced the profile of the participating NMRA and their staff. • WHO-PQ list has been used to offer exemptions or abbreviated approval by NMRAs when called for, facilitating quick access to good quality medicines. • Utilisation of reliable regulatory decisions • WHOPARs and WHOPIRs are used as references in expedited evaluation • PQ has provided lessons on how to utilise decisions from other agencies, institutions and experts without compromising independence and capacity building objectives.

7. Benefits from PQP (3) • Improved capacity for post-marketing quality monitoring: • Prequalified labs and related Quality Monitoring Projects has providedskills in sampling and testing of marketed products, Development of laboratory quality systems, Training of laboratory staff , Networking among laboratory analysts in the region. • Improved capacity and quality of local production • Training of manufacturers through seminars, workshops. • Advice through repeated assessment of dossier and GMP deficiencies at no cost. • Technical assistance provided to NMRAs and manufacturers • All training course materials are posted on the web site to assist manufacturers to prepare quality dossiers and readiness for inspections.

8. How have we utilized collaboration with PQP • Reviewed and strengthened registration and variation guidelines in the areas of the requirements for the Active Pharmaceutical Ingredient (API), Pharmaceutical Development, Efficacy (Clinical trials and Bioequivalence). • Reviewed and strengthened assessment procedures including assessment templates, details in reports and quality assurance measures (second review). • Pre-assessment of QC labs in preparation for WHO prequalification enabled us to improve Quality management Systems in our lab. • Helped in motivating for strengthening Pharmacovigilance systems • Improved communication and sharing of medicines information with other regulators and clients using the website • Improved our abbreviated assessment procedure for products already Prequalified and/or registered in ICH regions

9. Future plans (1) • Further strengthen cooperation between NMRAs and PQP • Work with PQP to disseminate understanding of PQP and strengthen PQP network by training of local and regional resource persons to be involved in Prequalification networking and trainings • Commitment to continued co-operation with PQP through involvement of our staff in PQP activities • To create networks among individual experts in the region participating in PQ assessment sessions and inspections • To discuss how PQP can be used as a catalyst for strengthening the capacity of NMRAs to regulate other medicines (Registration, GMP enforcement, Quality Control, Market surveillance, Pharmacovigilance) not under PQP. • Collaborate with PQP to catalyse harmonisation of regulatory activities in the EAC and in Africa in general.

10. Future plans (2) • Utilization of risk analysis principles applied by PQ in assessment of application for registration of products and variations, inspection of manufacturing sites and analysis of samples • Strengthen consideration and utilization of reliable regulatory decisions of other agencies, institutions and experts without compromising national obligations and the objective of capacity building. • Work with PQ to establish mechanisms of regular exchange of information on GMP status of manufacturing sites and assessment outcomes of products. • Explore how more NMRA staff can participate in the WHO Prequalification project. • Proceed with the process of getting our laboratory prequalified. • Collaborate with PQP in monitoring the performance of products approved by WHO and supplied under UN agencies and provide feedback on Drug quality (Post Marketing Surveillance) and Drug safety (Pharmacovigilance)

11. Conclusion • WHO prequalification of medicines programme: • Is responding to a real need – access to good quality medicines amidst gaps in QA systems • Is a vehicle for capacity building of NMRAs in developing countries • Is stimulating harmonization among DRAs, manufacturers and procurement agencies • Has stimulated improved GMP compliance among manufacturers – clear target standards with an assured international market • Will facilitates international pooled procurements

12. END • Quality must be built into a medicine and assured throughout the distribution and use chain. • Let us ALL work together to ensure that only safe, efficacious and good quality medicines are available for use by the patients. • We are committed to do our part in this partnership but we still need your support. MANY THANKS TO PQP